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Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder

Primary Purpose

Borderline Personality Disorder, Post-Traumatic Stress Disorders

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Crisis resolution
Sponsored by
Laddis, Andreas, M.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Borderline Personality Disorder focused on measuring Behavioral crisis, Perception of social crisis, Repetition compulsion, Intrusive mental events, Uncontrollable urges

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual In behavioral crisis Exclusion Criteria: Brain damage Currently intoxicated with alcohol or drugs or in withdrawal

Sites / Locations

  • Cape Cod and Islands Community Mental Health Center

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale (BPRS) scores
Scores on Client Observation and Client Interview, tools designed for this study

Secondary Outcome Measures

Patient interview and ratings for the value of the clinicians' interventions
Staff interview and ratings for their own interventions

Full Information

First Posted
December 21, 2005
Last Updated
February 17, 2006
Sponsor
Laddis, Andreas, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00269139
Brief Title
Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder
Official Title
Study of Outcome With an Intervention From the Cape Cod Model of Psychotherapy for Subjects in a Behavioral Crisis and With the Diagnosis of Borderline Personality Disorder (BPD) or Post-Traumatic Stress Disorder (PTSD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laddis, Andreas, M.D.

4. Oversight

5. Study Description

Brief Summary
Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction. The clinical hypothesis states, in two steps, that: the perception of a life crisis precedes and then underlies every behavioral crisis; the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.
Detailed Description
Subjects in the experimental group will be treated by Dr. Laddis after their admission to a crisis stabilization unit (CSU) or to an inpatient unit (IPU) for a behavioral crisis. Subjects will be included at random, as assigned to Dr. Laddis according to his routine duties at those units. Subjects in the control group will receive treatment for behavioral crisis according to the preference of the clinical staff at other comparable units. That treatment will constitute "treatment as usual". Clinicians in the control settings will not be informed about the experimental hypothesis, the clinical intervention and the contingent outcomes. The subjects will be tested for the results of treatment 12-24 hours after composition of a treatment plan. The testing will be done with the Brief Psychiatric Rating Scale (BPRS), as well as with a set of criteria devised by Dr. Laddis to measure the outward behavior and the mental events during behavioral crisis. The patients and the attending frontline staff will be interviewed also about their beliefs in regard to what, among the clinicians' interventions, made a difference for the course of the behavioral crisis, for better or for worse. The raters will be trained for interrater reliability and they will not be informed about the hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Post-Traumatic Stress Disorders
Keywords
Behavioral crisis, Perception of social crisis, Repetition compulsion, Intrusive mental events, Uncontrollable urges

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Crisis resolution
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS) scores
Title
Scores on Client Observation and Client Interview, tools designed for this study
Secondary Outcome Measure Information:
Title
Patient interview and ratings for the value of the clinicians' interventions
Title
Staff interview and ratings for their own interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with BPD or PTSD, with a structured interview according to the current diagnostic manual In behavioral crisis Exclusion Criteria: Brain damage Currently intoxicated with alcohol or drugs or in withdrawal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Laddis, MD
Phone
508-320-7895
Email
andreas.laddis@dmh.state.ma.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Laddis, MD
Organizational Affiliation
Cape Cod and Islands Community Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cape Cod and Islands Community Mental Health Center
City
Pocasset
State/Province
Massachusetts
ZIP/Postal Code
02559
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Laddis, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20420716
Citation
Laddis A. Outcome of crisis intervention for borderline personality disorder and post traumatic stress disorder: a model for modification of the mechanism of disorder in complex post traumatic syndromes. Ann Gen Psychiatry. 2010 Apr 27;9:19. doi: 10.1186/1744-859X-9-19.
Results Reference
derived

Learn more about this trial

Outcome of Crisis Intervention for Subjects With Borderline Personality Disorder or Post-Traumatic Stress Disorder

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